1. Field of the Invention
The present invention relates to medical testing devices, and particularly to an at-home cancer test that can be used by the layperson to obtain a qualitative indication of the presence of carcinoma.
2. Description of the Related Art
Cancer is a prevalent disease in modern society that often proves fatal. Most cancers are, however, potentially curable if diagnosed at an early stage in the disease. The American Cancer Society has identified seven major warning signs of cancer, including a change in bowel or bladder habits; a sore that does not heal; unusual bleeding or discharge; a lump in the breast or other parts of the body; chronic indigestion or difficulty in swallowing; obvious changes in a wart or mole; and persistent coughing or hoarseness.
While providing useful guidelines, it is often difficult for many lay persons to apply the signs to changes in their own bodies due to a lack of objectivity, a lack of sensitivity, the gradual onset of changes, etc. For example, in the case of breast cancer, the hallmark diagnostic sign is the persistence of a dominant mass (i.e., a hard mass) over time. Many women, however, are unable to effectively palpate their own breasts, either through lack of proper training in the procedure, the presence of benign cysts in large pendulous breasts (e.g., fibrocystic disease), qualitative judgments as to the hardness or softness of a mass, apparent shifts in the location of the mass, etc. Similar problems are experienced by men in palpation for testicular cancer, a process often neglected due to its distasteful nature.
The lay person who cannot effectively perform a self-evaluation, but is concerned with the risk of developing cancer, is left with no choice but to visit a doctor or other medical professional, often with great frequency and at the risk of developing a “Peter and the Wolf” syndrome, or incurring the expense of medical testing, such as x-rays, aspirations, biopsies, enzyme assays, antibody titers, etc.
There are many people who fall into certain well-defined profiles that render them more at risk to develop certain forms of cancer than the general population. For example, certain women with large breasts, a Semitic ethnic background, and a family history of breast cancer are apt to be at higher risk for developing breast cancer than the general population. Moreover, persons who have been treated for cancer that has gone into remission need to be vigilant in promptly detecting a recurrence of the cancer. In each of these cases, early detection of the cancer is the key to effective and potentially curative treatment.
Tanaka et al. report studies detecting β-core from Urinary Gonadotropin Peptides (UGP) in Clinical Chemistry, Vol. 4.0, No. 12, pp. 2317-18 (1994) using three kits, one of which was released for research purposes, and another of which was produced in Japan but not yet approved for use by the Japanese government. The structure and method of use of the kits is not described. However, it is clear that the kits are immunoassay kits. As noted by Cole et al. in Clinical Chemistry, Vol. 47, No. 2, pp. 308-315 (1994), such immunoassays are usually quantitative tests, often use polyclonal antibodies, are automated, require considerable sample preparation, are performed in laboratories, and are noted for the complexity of the procedure, the extensive pipetting, their relative imprecision, and time-consuming procedures. Such considerations generally militate against the use of immunoassays for home use by laypersons. For similar reasons, the immunoassays described by Nishimura et al. in Molecular Medicine, Vol. 39, Ovarian Cancer:Methods and Protocols pp. 135-141 (Humanas Press, Inc., Totowa, N.J.; by Saller et al. in Clinical Chemistry 36(2): 234-239 (February 1990); by WO 96/29430, published Sep. 26, 1996; and by WO 01/64941, published Feb. 29, 2000, are not appropriate for home use, as they are multi-step procedure involving multiple reagents and automated processes more suited for the laboratory than by the lay person.
For these reasons, a quick, painless, easy-to-use test kit that the lay person might use in the privacy of his or her home to provide a qualitative early warning signal of the presence of carcinoma so that the lay person can feel comfortable in seeking appropriate confirmation and treatment from a medical professional is desired. None of the above inventions, publications, and patents, taken either singly or in combination, is seen to describe the instant invention as claimed. Thus, an at home cancer test solving the aforementioned problems is desired.